60 Participants Needed

AZD0754 for Prostate Cancer

(APOLLO Trial)

Recruiting at 8 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: AstraZeneca
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, tolerability, and antitumour activity of AZD0754 CAR T-cell therapy in participants with metastatic prostate cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must continue any medical castration therapy if you are on it, and you cannot receive certain full-dose anticoagulants or recent anticancer therapies close to the study start. It's best to discuss your specific medications with the study team.

What safety data exists for AZD0754 in humans?

There is no specific safety data available for AZD0754, but a similar compound, AZD3514, has been evaluated in clinical trials for prostate cancer, showing it is generally safe in humans.12345

How does the drug AZD0754 differ from other prostate cancer treatments?

AZD0754 is unique because it likely targets androgen receptor (AR) signaling, similar to AZD3514, which inhibits both androgen-dependent and independent AR signaling. This approach is particularly important for treating castration-resistant prostate cancer, where traditional hormone therapies fail.13678

Eligibility Criteria

This trial is for individuals with metastatic prostate cancer. Participants should meet specific health criteria to be eligible, but the exact inclusion and exclusion details are not provided.

Inclusion Criteria

My prostate cancer is growing despite hormone therapy.
My prostate cancer has spread, and it's not small cell or neuroendocrine type.
I have had treatments like abiraterone or taxane for prostate cancer, or I cannot or will not take taxane.
See 8 more

Exclusion Criteria

Participants with prior solid organ transplantation
I had cancer before, but it was treated over 2 years ago and is not likely to come back.
I have brain metastases.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD0754 CAR T-cell therapy to evaluate safety, tolerability, and antitumour activity

Variable, up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

  • AZD0754
Trial OverviewThe study is testing AZD0754 CAR T-cell therapy's safety, how well people can handle it, and its effectiveness in treating metastatic prostate cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: AZD0754Experimental Treatment1 Intervention
AZD0754 monotherapy for treatment of participants with metastatic prostate cancer.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

AZD3514 is an orally bioavailable drug that effectively inhibits both androgen-dependent and -independent signaling of the androgen receptor (AR), which is crucial for treating castration-resistant prostate cancer (CRPC).
The drug works through two mechanisms: it prevents the nuclear translocation of the AR and reduces the overall levels of the receptor, demonstrating significant antitumor activity in animal models, including juvenile male rats and the HID28 mouse model of CRPC.
AZD3514: a small molecule that modulates androgen receptor signaling and function in vitro and in vivo.Loddick, SA., Ross, SJ., Thomason, AG., et al.[2021]
In a 7-year study involving patients with early, non-metastatic prostate cancer, adding bicalutamide (150 mg) to standard care significantly improved progression-free survival (PFS) for those with locally advanced disease, reducing the risk of progression by 34%.
However, in cases of localized disease, bicalutamide did not show a significant benefit in PFS, and there was no difference in overall survival between the treatment and standard care groups.
Bicalutamide (Casodex) 150 mg plus standard care in early non-metastatic prostate cancer: results from Early Prostate Cancer Trial 24 at a median 7 years' follow-up.Wirth, M., Tyrrell, C., Delaere, K., et al.[2014]
The study developed and validated an immunohistochemistry (IHC) method to assess androgen receptor (AR) levels in circulating tumor cells (CTCs) for patients undergoing treatment with AZD3514, a drug targeting prostate cancer.
Initial reproducibility tests showed almost perfect agreement between operators in scoring AR positivity (κ=0.94), but a bias in staining intensity was corrected through additional training, improving agreement to κ=0.81, demonstrating the method's reliability and potential for broader application in IHC techniques.
Optimisation of an immunohistochemistry method for the determination of androgen receptor expression levels in circulating tumour cells.Cummings, J., Sloane, R., Morris, K., et al.[2021]

References

AZD3514: a small molecule that modulates androgen receptor signaling and function in vitro and in vivo. [2021]
Bicalutamide (Casodex) 150 mg plus standard care in early non-metastatic prostate cancer: results from Early Prostate Cancer Trial 24 at a median 7 years' follow-up. [2014]
Optimisation of an immunohistochemistry method for the determination of androgen receptor expression levels in circulating tumour cells. [2021]
Efficacy of combined androgen blockade with zoledronic acid treatment in prostate cancer with bone metastasis: the ZABTON-PC (zoledronic acid/androgen blockade trial on prostate cancer) study. [2022]
Docetaxel with or without zoledronic acid for castration-resistant prostate cancer. [2021]
Multidrug resistance protein 4 (MRP4) expression in prostate cancer is associated with androgen signaling and decreases with tumor progression. [2021]
AR-regulated ZIC5 contributes to the aggressiveness of prostate cancer. [2022]
Predictive value of AZGP1 following radical prostatectomy for prostate cancer: a cohort study and meta-analysis. [2020]